BEUDAMED
    12 results · 21ms · Sources: EU EUDAMED, US FDA

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    LithoVue System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Ophthalmic Speculum

    FDA UDI
    KATENA PRODUCTS, INC.·00841668100141·KRATZ-BARRAQUER HEAVY WIRE SPECULUM

    TSRH SPINAL SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ALARIS SAFETY MALE LUER

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 13, 2025

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 8, 2013

    840 VENTILATOR

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY NELLCO·Product code CBK·June 17, 2011

    PFC SIGMARP STB TB IN 4 10.0

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS, DEPUY CORK·Product code NJL·September 5, 2008

    UNKNOWN

    FDA Adverse Event
    Injury ·COOK BIOTECH·Product code PAG·March 22, 2019

    TEXIUM CLOSED MALE LUER WITH FEMAILE CAP

    FDA Adverse Event
    Malfunction ·CAREFUSION NORTH CAROLINA·Product code FPA·July 6, 2020

    Synthes Ti Button Plate 7 Holes, Fastener, Fixation, nondegradable, Soft Tissue

    FDA Enforcement
    Class II ·Terminated·Synthes (USA) Products LLC·July 13, 2016

    IGuide System, software versions: 2.2.0, 2.2.1, 2.2.2 Product Usage: Linear Accelerator. The intended use of the device is the control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment.

    FDA Enforcement
    Class II ·Terminated·Medical Intelligence Medizintechnik Gmbh·July 31, 2019